Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness — HYALU-LAUDE  

Vaginal Disease Clinical Trial

Official title: Clinical Investigation to Evaluate the Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness

Status Completed

Clinical Trial Summary

This study evaluates the efficacy and safety of a new hyaluronic acid-based vaginal moisturizer gel to ease symptoms of vaginal dryness compared to a commonly used marketed vaginal moisturizer (Cumluade Hidratante Interno®).

Clinical Trial Description

This is a prospective, multicenter, randomized, controlled, double-blind clinical investigation to evaluate the safety and efficacy of a new hyaluronic acid-based vaginal moisturizer gel (medical device class IIb) in women with symptoms of vaginal atrophy and dryness, compared to a commonly used marketed vaginal moisturizer in gynecology clinics (Cumluade Hidratante Interno®), with a 1-month follow-up. The participants will apply the single dose of vaginal moisturizer 3 times per week, every other day, preferably in the evening. The investigators will monitor the evolution of vaginal symptoms, vaginal health using the Vaginal Health Index (VHI), sexual function using the Female Sexual Function Index (FSFI) questionnaire, and the safety and tolerability of the new class IIb medical device. ;

Related Conditions & MeSH terms

• Vaginal Disease
• Vaginal Diseases

• NCT number: NCT05888116
• Study type: Interventional
• Source: Dermofarm, S.A.U
• Status: Completed
• Phase: N/A
• Start date: May 23, 2023
• Completion date: October 18, 2023